Long-term Open-label Study of Zigakibart Injection for Adults with Primary IgA Nephropathy

What this Trial Is About

This research evaluates the long-term safety and tolerability of zigakibart in adults with immunoglobulin A nephropathy IgAN. It is an open-label extension study for patients who have completed previous zigakibart trials. The study aims to determine whether zigakibart can be safely used over extended periods in people with this kidney condition. Participants will receive zigakibart as a subcutaneous injection at a dose of 600 mg every two weeks. This extension study follows earlier phase 12 and phase 3 trials and includes patients from these studies. The treatment period is designed to assess continued safety and effects over time during this open-label phase. During the study, participants will have regular assessments including monitoring for adverse events, laboratory tests measuring kidney function, immunoglobulin levels, and drug concentrations. Researchers will track safety lab results, vital signs, and antibody development. The study includes follow-up visits up to several years to evaluate long-term safety and kidney health outcomes such as proteinuria and estimated glomerular filtration rate eGFR.

Open-label Extension Study of Zigakibart in Adults With IgA Nephropathy.